Back to resultsPhase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ACZONE Gel, 5%
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, G6PD deficiency, Dapsone
Eligibility Criteria
Inclusion Criteria: To be eligible for this study, subjects must fulfill all of the following criteria: Male or female ≥12 years of age. A clear diagnosis of acne vulgaris, defined as ≥20 acne inflammatory and/or non-inflammatory lesions (≥10 of the acne lesions must be on the face, the others may be present on the neck, shoulders, upper chest, and upper back) at screening. A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal for the central reference laboratory. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: A dermal examination reveals the presence of severe cystic acne or acne conglobata. Treatment with isotretinoin (Accutane®) within 3 months of baseline and throughout the study. Subjects predisposed to anemia for other medical reasons, including but not limited to gastrointestinal bleeding and cancer. Subjects who are using topical or systemic medications for acne throughout the study. This includes, but is not limited to, benzoyl peroxide, antibiotics, topical Vitamin A derivatives such as Retin-A. Subjects who are using medication or eating foods that could potentially cause a hemolytic event in individuals with G6PD deficiency during the study. Facial surgery (dermabrasion, laser resurfacing or other facial cosmetic surgeries) within 3 months of baseline and throughout the study. A history of hypersensitivity to dapsone, parabens, or any component of the study products.
Sites / Locations
- Radiant Research, Inc.
- Therapeutics Clinical Research
- Department of Dermatology, University of California, San Francisco
- Dermatology Associates, PC at the Washington Hospital Center
- Howard University Hospital Department of Dermatology
- FXM Research
- University Clinical Research, Inc
- MedaPhase, Inc.
- Boston Clinical Trials
- Henry Ford Medical Center - New Center One
- Washington University Dermatology Clinical Trials Unit
- Skin Specialists, PC
- Department of Dermatology SUNY Downstate Medical Center
- Columbia University Medical Center Department of Dermatology
- Metrolina Medical Research
- Universtiy Dermatology Consultants, Inc.
- Paddington Testing Clinic
- Society Hill Dermatology
- Okatie Research Center, LLC
- Dermatology Associates of Knoxville
- Dermatology Research Associates
- DermResearch, Inc.
- DiscoveResearch, Inc.
- J&S Studies, Inc.
- Research Across America
- Suzanne Bruce and Associates, PA
- The Education and Research Foundation, Inc.
- Virginia Clinical Research
- Advanced Healthcare, SC
Outcomes
Primary Outcome Measures
The within-subject between treatment period differences in change from baseline to the 2nd week of each treatment period and change from baseline to the end of each treatment period will be summarized based upon various lab parameters.
The safety evaluable data set will be used, and each variable will be summarized using descriptive statistics.
Analyses of clinical lab values, AEs, vitals, and concomitant meds will be performed on all subjects who received treatment.
Secondary Outcome Measures
Acne Lesions: Tabular summaries of total lesion counts will be provided by appropriate descriptive statistics.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00243542
Brief Title
Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency
Official Title
ACZ ACN 01. A Phase 4, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Cross-Over Study to Further Evaluate the Risk of Hematological Adverse Events in G6PD-Deficient Subjects With Acne Vulgaris Treated With ACZONE™ (Dapsone) Gel, 5%.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to gather more information about the safety of ACZONE Gel, 5% in treating subjects with acne who have certain blood disorders.
ACZONE Gel, 5% is a prescription skin use (topical) medicine used to help treat acne in people 12 years and older. ACZONE Gel, 5% has been studied in approximately 4000 people and was shown to reduce the number of pimples and improve acne.
The active drug ingredient in ACZONE Gel, 5% is dapsone. People with blood disorders called "G6PD deficiency", "methemoglobin reductase deficiency", and "hemoglobin M" have a higher chance of side effects with dapsone.
G6PD is short for "glucose-6-phosphate dehydrogenase". It is an enzyme found in red blood cells, which carry oxygen to all parts of the body. G6PD helps the red blood cells to function normally. Some people have less G6PD in their red blood cells than the average person. This is called G6PD deficiency.
Two treatments - ACZONE Gel, 5% and placebo - will be studied for comparison.
Detailed Description
Study Objectives:
To compare the safety profile and risk of hemolysis of ACZONE Gel, 5% to that of the vehicle after 12 weeks each of twice daily applications in acne vulgaris subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
To determine the systemic levels of plasma dapsone and N-acetyl dapsone during treatment with ACZONE Gel, 5%.
Study Population:
Approximately 60 male and female subjects
Study Treatment:
All subjects in the study will receive ACZONE Gel, 5% and vehicle in 1 of 2 sequences; each for a 12-week period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne, G6PD deficiency, Dapsone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ACZONE Gel, 5%
Intervention Type
Drug
Intervention Name(s)
Vehicle
Primary Outcome Measure Information:
Title
The within-subject between treatment period differences in change from baseline to the 2nd week of each treatment period and change from baseline to the end of each treatment period will be summarized based upon various lab parameters.
Title
The safety evaluable data set will be used, and each variable will be summarized using descriptive statistics.
Title
Analyses of clinical lab values, AEs, vitals, and concomitant meds will be performed on all subjects who received treatment.
Secondary Outcome Measure Information:
Title
Acne Lesions: Tabular summaries of total lesion counts will be provided by appropriate descriptive statistics.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be eligible for this study, subjects must fulfill all of the following criteria:
Male or female ≥12 years of age.
A clear diagnosis of acne vulgaris, defined as ≥20 acne inflammatory and/or non-inflammatory lesions (≥10 of the acne lesions must be on the face, the others may be present on the neck, shoulders, upper chest, and upper back) at screening.
A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal for the central reference laboratory.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
A dermal examination reveals the presence of severe cystic acne or acne conglobata.
Treatment with isotretinoin (Accutane®) within 3 months of baseline and throughout the study.
Subjects predisposed to anemia for other medical reasons, including but not limited to gastrointestinal bleeding and cancer.
Subjects who are using topical or systemic medications for acne throughout the study. This includes, but is not limited to, benzoyl peroxide, antibiotics, topical Vitamin A derivatives such as Retin-A.
Subjects who are using medication or eating foods that could potentially cause a hemolytic event in individuals with G6PD deficiency during the study.
Facial surgery (dermabrasion, laser resurfacing or other facial cosmetic surgeries) within 3 months of baseline and throughout the study.
A history of hypersensitivity to dapsone, parabens, or any component of the study products.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Garrett, MS, DDS
Organizational Affiliation
QLT USA, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Department of Dermatology, University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Dermatology Associates, PC at the Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Howard University Hospital Department of Dermatology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
FXM Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
University Clinical Research, Inc
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
MedaPhase, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Henry Ford Medical Center - New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University Dermatology Clinical Trials Unit
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Department of Dermatology SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Columbia University Medical Center Department of Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Metrolina Medical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Universtiy Dermatology Consultants, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Paddington Testing Clinic
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Society Hill Dermatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-6129
Country
United States
Facility Name
Okatie Research Center, LLC
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29907'
Country
United States
Facility Name
Dermatology Associates of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
Dermatology Research Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
DiscoveResearch, Inc.
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
J&S Studies, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Suzanne Bruce and Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
The Education and Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Virginia Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Advanced Healthcare, SC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19075138
Citation
Piette WW, Taylor S, Pariser D, Jarratt M, Sheth P, Wilson D. Hematologic safety of dapsone gel, 5%, for topical treatment of acne vulgaris. Arch Dermatol. 2008 Dec;144(12):1564-70. doi: 10.1001/archdermatol.2008.518.
Results Reference
derived
Learn more about this trial
Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency
We'll reach out to this number within 24 hrs